Shandra Eisenga Human Cell and Tissue Product Safety Act

Floor Speech

BREAK IN TRANSCRIPT

Mrs. DINGELL. Mr. Speaker, I thank Ms. Castor for yielding to me. I also thank my colleagues on the other side of the aisle and, in particular, my dear friend, John Moolenaar. We have been a team on this from the moment that we heard about this.

Mr. Speaker, I rise today to share my strong support for H.R. 7188, the Shandra Eisenga Human Cell and Tissue Product Safety Act.

I am proud to lead this bipartisan bill alongside my friend and colleague from Michigan, Mr. Moolenaar.

Last summer, I was contacted by the medical director of the Washtenaw County Tuberculosis Clinic, who was treating a patient, Shandra Eisenga, for a severe post-surgical tuberculosis infection. Shandra was Representative Moolenaar's constituent, but she was being treated at the University of Michigan, a medical facility in my district. After a month of battling a severe TB infection in the intensive care unit, she unfortunately died.

Since Shandra's passing, it has been discovered that her death was, indeed, linked to contaminated bone graft material produced by Aziyo Biologics. She was 1 of 36 patients who received material from the contaminated lot. As of today, this latest outbreak is linked to the deaths of two patients, including Shandra.

This bill requires the Department of Health and Human Services to conduct public awareness campaigns to assist in preventing TB outbreaks caused by contaminated human cell and tissue product donations. We have also included an important provision to allow the Food and Drug Administration to pursue civil penalties from establishments that manufacture human cells, tissues, and cellular- and tissue-based products where they put the patient at risk.

Patients and their healthcare providers deserve to know the risks associated with tissue donations, and companies that make and distribute contaminated products must be held accountable for their actions that put patients in harm's way.

Mr. Speaker, when this happened, I had had multiple bone grafts because of osteomyelitis. I never once was warned of any danger, and my doctor was unaware of these dangers. We cannot let that ever happen again. We must protect patients and educate patients.

I thank Energy and Commerce Chair Cathy McMorris Rodgers and Ranking Member Frank Pallone for fighting for this important piece of legislation. Again, I would not be here without my colleague, Representative Moolenaar.

We owe it to Shandra and her family, who is here and to whom we made a commitment last August that we would not let this happen to anybody else again. I am happy that they see us here fighting for them on this floor. We are also here for any other patient who has been affected by contaminated bone grafts. We are going to prevent these unnecessary tragedies from happening again.

Mr. Speaker, I urge my colleagues to vote ``yes,'' and I reserve the balance of my time.

BREAK IN TRANSCRIPT

Source